Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 4:18 AM
Study NCT ID:
NCT00006360
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2000-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Study Overview
Official Title:
Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III oropharyngeal cancer.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III oropharyngeal cancer.
Detailed Description:
OBJECTIVES:
* Assess target coverage and major salivary gland sparing in patients with stage II or III oropharyngeal cancer treated with intensity-modulated radiotherapy.
* Determine the nature and prevalence of acute and late side effects of this treatment in these patients.
* Determine the rate and pattern of locoregional tumor recurrence in these patients after this treatment.
OUTLINE: This is a multicenter study.
Patients receive 3-D conformal radiotherapy and/or intensity-modulated radiotherapy daily 5 days a week for 6 weeks, in an effort to spare major salivary glands.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 57-64 patients will be accrued for this study over 27 months.
* Assess target coverage and major salivary gland sparing in patients with stage II or III oropharyngeal cancer treated with intensity-modulated radiotherapy.
* Determine the nature and prevalence of acute and late side effects of this treatment in these patients.
* Determine the rate and pattern of locoregional tumor recurrence in these patients after this treatment.
OUTLINE: This is a multicenter study.
Patients receive 3-D conformal radiotherapy and/or intensity-modulated radiotherapy daily 5 days a week for 6 weeks, in an effort to spare major salivary glands.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 57-64 patients will be accrued for this study over 27 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: